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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K093155
Device Name VASHE WOUND CLEANSING SYSTEM
Applicant
Puricore, Inc.
508 Lapp Rd.
Malvern,  PA  19355
Applicant Contact DENNIS MAHONEY
Correspondent
Puricore, Inc.
508 Lapp Rd.
Malvern,  PA  19355
Correspondent Contact DENNIS MAHONEY
Classification Product Code
FRO  
Date Received10/06/2009
Decision Date 03/01/2010
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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